Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-12-31

Brief Summary

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The objective of this study is to evaluate the effect of vitamin D supplementation on thyroid autoimmunity, thyroid function, and other metabolic and clinical variables associated with the thyroid axis in patients with Hashimoto's thyroiditis and vitamin D deficiency.

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Detailed Description

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Conditions

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Hashimoto Disease Treatment Levothyroxine Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients will randomly receive the experimental condition or the active comparator for 3 months. After 3 months of washout, the groups will be crossed to receive the opposite treatment.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D-correction

Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.

Group Type EXPERIMENTAL

Vitamin D-correction

Intervention Type DIETARY_SUPPLEMENT

Capsule with 50.000 UI cholecalciferol

Vitamin D-RDA

Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.

Group Type ACTIVE_COMPARATOR

Vitamin D-RDA

Intervention Type DIETARY_SUPPLEMENT

Capsule with 4.2000 UI cholecalciferol

Interventions

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Vitamin D-correction

Capsule with 50.000 UI cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Vitamin D-RDA

Capsule with 4.2000 UI cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* women between 18-45 years old (pre-menopausal stage)
* men between 18-60 years old
* BMI between 18.5-34.9 kg/ m2
* medical diagnosis of Hashimoto's thyroiditis
* treatment with levothyroxine (LT4) with stable dose (from four months from the start of the intervention)
* positive antithyroid antibody (peroxidase and/or thyroglobulin)
* serum 25 (OH) D levels \<20 ng / ml.

Exclusion Criteria

* radioiodine, thyroidectomy, antithyroid treatment
* disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin D metabolism.
* disorder of kidney, liver, or bone-metabolic function
* Graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, Turner or Down syndrome, primary hyperparathyroidism
* vitamin D, calcium, complex B, omega-3 supplements
* pregnant or breastfeeding
* type 2 diabetes or dyslipidemia with drug treatment at unstable doses
* intense physical activity

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes